AVAILABLE NOW!
3rd Edition Revised CTP Inspection Checklist
The 3rd Edition Inspection Checklist has been recently revised and it is now available for download. Please Click Here to view or download the document.
3rd Edition CTP Accreditation Manual
The Accreditation Manual for the 3rd edition of the FACT- JACIE International Standards for Cellular Therapy Product Collection Processing and Administration is now available for download and/or purchase.
The purpose of the Accreditation Manual is to provide guidance to applicants for accreditation and to onsite inspectors. The manual is intended to explain the intent and rationale for specific standards and to provide explanations, examples, and alternative approaches that will be helpful in the accreditation process.
To enhance the educational value of the Accreditation Manual, this document will be revised as needed on a periodic basis. Notification of changes will be distributed via the Just the FACT's quarterly newsletter. As users of the manual, we appreciate all feedback and questions regarding the manual. Please send comments and suggestions to FACT@unmc.edu.
3rd Edition Cord Blood Accreditation Manual
The Guidance Document to accompany the NETCORD-FACT International Standards for Cord Blood Collection, Processing,Testing, Banking, Selection and Release, Third Edition is available for download and/or purchase.
The purpose of the Accreditation Manual is to provide guidance to applicants for accreditation and to on-site inspectors. This manual is intended to explain the intent and rationale for specific standards, and to provide explanations, examples, and alternative approaches that will be helpful in the accreditation process. There are many effective mechanisms by which to achieve compliance with NetCord-FACT Standards; this manual does not contain an exhaustive list of ways to meet the standards but provides some examples of how the standards can be met.
3rd Edition Revised CTP Document Checklist
The 3rd Edition Document Checklist has been recently revised and it is now available for download. Please Click here to view or download the document.
CTP Inspection & Accreditation Workshop
San Diego, CA ( February 12, 2008)
FACT unveiled its new training workshop format at the CTP Inspection & Accreditation Workshop in San Diego, CA, on February 12, 2008. Based upon feedback from past participants, the new format included more participant interaction and real-world examples. The new format was a success, with participants indicating on average either agreement or strong agreement that each session was presented in an interesting, effective, and organized manner.
In addition to asking questions during the workshop, participants were encouraged to ask any remaining questions via the workshop evaluation form or via email. Click here for questions the FACT office has received, with the answers provided.
NEWS
FACT Announces New 2008 Accreditations
Two new blood and marrow transplant programs earned accreditation and seventeen facilities received accreditation during the first quarter of 2008. See the list of recently accredited facilities.
World Leaders in Cellular Therapy at the 14th ISCT Annual Meeting - May 17-20, 2008
One of FACT's parent organizations, the International Society for Cellular Therapy (ISCT), is hosting its 14th Annual Meeting on May 17-20, 2008, at the Miami Convention Center & Hyatt Regency Miami in Miami, Florida. The program contains cellular therapy sessions and exciting cutting edge science. The Organizers are planning the meeting around diseases with active research and clinical trials in Regenerative Medicine and Stem Cell Biology, and have included world experts in diabetes, cardiology, neurology, cancer, and immunotherapy. Details regarding the Annual Meeting, including a Preliminary Program Update, can be found here. Register for this exciting opportunity today!
ISCT was established in 1992 to provide a global forum for developing and supporting innovative cellular therapies through several resources. This professional organization is for those working or interested in cell-based research, processing, manipulation, and clinical translation. Information regarding ISCT can be found on its website.
Fourth Edition of FACT-JACIE International Standards for Cellular Therapy Product Collection, Processing and Administration Currently Under Development
FACT and JACIE are currently developing the fourth edition of the FACT-JACIE International Standards for Cellular Therapy Product Collection, Processing and Administration. The draft Standards will be posted in July 2008 for a 90-day public comment period, and the final Standards will be published in November 2008. FACT encourages all stakeholders to comment on the Standards. An exciting addition to the standards development process for this edition is the concurrent development of the accompanying Accreditation Manual, which provides guidance on the intent of the Standards and examples of how to be in compliance with the requirements. Stay tuned for more information regarding the public comment process.
FACT's Quality Assurance Coordinator Receives ASQ-Certified Manager of Quality/Organizational Excellence
The Certification Board of the American Society for Quality is pleased to announce that Jill C. Hempel has completed the requirements to be named an ASQ-Certified Manager of Quality/Organizational Excellence. As such, Ms. Hempel has reached a signifcant level of professional recognition, indicating a proficiency in and a comprehension of quality management principles and practices. For more information regarding Jill's achievement and the ASQ in general, click here.
Information and Announcements from the U.S. Food and Drug Administration
The U.S. Food and Drug Administration posts regular updates to its website. For current updates pertaining to cellular therapy, visit our Regulatory Updates page.
Q & A
Do you have a question regarding the FACT Accreditation Process or its Standards? Submit your inquiry to the FACT Accreditation Office at fact@unmc.edu.
For frequently asked questions, visit our FAQ pages:
CTP FAQ Page
CBB FAQ Page
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Is there something else you would like to see on the website? Are you finding what you need quickly and easily? Do you have suggestions on how we can meet your needs better? We appreciate all feedback on the website and its content. Please send comments and suggestions to: FACT@unmc.edu Thank you.
